Rocket Medical recalls 16Fg Seldinger Catheter Procedure Tray (model R54549-16-PK) due to misleading labeling that may cause the tray to fall during medical procedures.
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Rocket Medical is recalling its 16Fg Seldinger Catheter Procedure Tray (model R54549-16-PK) because the labeling might lead to improper securing, increasing the risk of the tray falling during use. This could potentially cause injury to the patient or healthcare provider.
The tray's labeling contains misleading statements that could result in it not being secured properly. If the tray falls during a medical procedure, it might cause injury to the patient or healthcare provider.
Healthcare professionals using the Rocket 16Fg Seldinger Catheter Procedure Tray for chest tube procedures are most at risk. Patients receiving care during these procedures may also be affected.
Check for the model number R54549-16-PK on the tray. The product was sold with lot codes 496659, 497629, 496918, 499814, 497077, or 500408.
Review the tray's labeling for misleading statements that could cause improper securing.
The labeling contains misleading statements that could lead to improper securing, increasing the risk of the tray falling during use.
Model R54549-16-PK with lot codes 496659, 497629, 496918, 499814, 497077, or 500408.
The recall does not require immediate stop use; however, you should check the labeling for potential issues before use.
We’ve drafted a message you can send Rocket to request your refund or repair — edit it as you like.
Subject: Recall Z-0954-2026 — Rocket Rocket Hello, I own a Rocket that is covered by recall Z-0954-2026 from Rocket. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
